NON-SURGICAL TREATMENT of PERI-IMPLANTITIS with or WITHOUT SYSTEMIC AZITHROMYCIN: a RANDOMIZED CLINICAL TRIAL in HUMANS
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in probing depth
研究概览
简要总结
The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months.
This study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis.
The treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).
详细描述
Peri-implantitis is defined as the pathological alteration associated with plaque that occurs in the tissues surrounding dental implants, characterized by inflammation of the peri-implant mucosa and subsequent progressive loss of supporting bone. Bacterial colonization of the implant surface in a susceptible subject is considered the primary etiological factor of this pathology. Case series and clinical trials have demonstrated an additional benefit when using systemic antibiotics such as ornidazole or metronidazole after non-surgical treatment of peri-implantitis.
The rationale for conducting this clinical trial lies in the lack of randomized studies that have tested the non-surgical treatment of peri-implantitis with shorter antibiotic regimens and their potential impact on systemic health.
The primary objective of this randomized clinical trial is to evaluate the change in probing depth at 12 months in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) as an adjunct to the non-surgical treatment of peri-implantitis.
The secondary objective is to assess clinical, radiographic, and microbiological changes at 3, 6, and 12 months. Additionally, systemic biomarkers, complete blood count, glycosylated hemoglobin and creatinine will be evaluated at day 7, and 3, 6, and 12 months. Endothelial function (endothelium-dependent vasodilation measured in the brachial artery) and subclinical atherosclerosis (measurement of carotid artery intima-media thickness) will be evaluated at 12 months.
Design: This research is designed as a 1-year randomized controlled trial (RCT), with 2 parallel groups, triple-blind, and placebo-controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years;
- •absence of systemic pathology contraindicating treatment;
- •presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;
- •absence of implant mobility;
- •patients without periodontitis or with treated periodontitis;
- •patients who understand the treatment and are willing to comply with it by providing written informed consent.
排除标准
- •smokers ≥10 cigarettes/day;
- •diabetic patients (HbA1c level ≥6,5%);
- •pregnant or breastfeeding women;
- •use of antibiotics, corticosteroids, and/or immunosuppressive treatment in the 3 months prior to the start of the study;
- •allergy to azithromycin;
- •patients with a history of bisphosphonate treatment;
- •chronic consumption of non-steroidal anti-inflammatory drugs;
- •bone loss exceeding the apex of the implant;
- •prosthesis that does not allow access to peri-implantitis treatment
研究组 & 干预措施
Azithromycin 500 mg
Systemic antibiotic: Azithromycin 500 mg every 24 hours for 3 days
干预措施: Azithromcyin (Drug)
Placebo
Same shape, size and dosage as test
干预措施: Placebo (Other)
结局指标
主要结局
Change in probing depth
时间窗: From enrollment to the end of treatment at 12 months
The change in probing depth (quantitative dependent variable) at 12 months will be measured in millimeters as the distance from the mucosal margin to the bottom of the peri-implant pocket, using a millimetric CP15 UNC Hu-Friedy probe. The change in probing depth will also be measured at 3 and 6 months.
次要结局
- Recession(From enrollment to the end of treatment at 12 months)
- Clinical attachment level(From enrollment to the end of treatment at 12 months)
- Bleeding index(From enrollment to the end of treatment at 12 months)
- Plaque index(From enrollment to the end of treatment at 12 months)
- Width of the keratinized mucosa(From enrollment to the end of treatment at 12 months)
- Changes in radiographic bone level(From enrollment to the end of treatment at 12 months)
- Change in bacterial load(From enrollment to the end of treatment at 12 months)
- Implant survival(From enrollment to the end of treatment at 12 months)
- Endothelial function(From enrollment to the end of treatment at 12 months)
- Subclinical atherosclerosis(From enrollment to the end of treatment at 12 months)
- Concentration of inflammatory cytokines biomarkers(From enrollment to the end of treatment at 12 months)
- Concentration of endothelial activation/injury markers(From enrollment to the end of treatment at 12 months)
- Concentration of serum C-reactive protein(From enrollment to the end of treatment at 12 months)
- Concentration of serum amyloid A(From enrollment to the end of treatment at 12 months)
- Concentration of circulating blood cells(From enrollment to the end of treatment at 12 months)
- Concentration of high-sensitivity CRP(From enrollment to the end of treatment at 12 months)
- Rate of lipid fractions(From enrollment to the end of treatment at 12 months)
- Treatment success(From enrollment to the end of treatment at 12 months)
研究者
Juan Blanco Carrión
Associate Professor
University of Santiago de Compostela